Men Who Have Sex With Men (MSM) Neurocog 1&2 Study (MSM Neurocog)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01508559
First received: January 9, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The treatment of HIV and the tests performed for HIV care have changed over the last 20 years but improvement of management of HIV-infected subjects is still warranted. The investigators would like to collect and analyse clinical information obtained from subjects who are between 18 and 50 years of age. The investigators will look at routine clinic information such as blood pressure, recent blood test results and clinical history. The investigators will then assess cognitive (brain) function by talking and/or written tests. These tests will include tests for memory, depression and anxiety.

All of those who are identified as having problems with their brain function in this way will be offered onward referral for further assessment as appropriate. Those taking part will be offered a follow up visit at 24-48 weeks after the first assessment to see if there are any changes. This will allow us to understand how brain problems develop, get worse, or get better over time. No genetic research will be done. Depression is a mental health condition that can be characterized by negative feelings, a generally low mood, or problems with eating and sleeping normally. Anxiety is also a mental health condition where a person can feel general anxiousness or fear of specific situations, or, in more serious cases, can have panic attacks. Impaired brain function is a condition of the nervous system or brain where the brain does not function as well as it normally should, and can include symptoms such as forgetfulness, doing everyday tasks more slowly or becoming disorientated to the time of day or the place one is in.

For this study, the investigators will also collect data from medical records, including (and if known)social and educational-related data, HIV infection-related data (e.g. date of diagnosis, blood test results), relevant medical history (e.g. previous psychiatric conditions) and medication used (e.g. date started, the drugs used).

The information the investigators will get from this study will be used to inform healthcare providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to routinely assess HIV infected patients for the presence of anxiety/depression and impaired brain function. The investigators will also get information on whether the treatments used for HIV infection make a difference to how commonly these conditions occur in patients.


Condition
HIV Related Neurocognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Function in a Central London Cohort of HIV Infected and Uninfected Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Neurocognitive screening score [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    To describe the prevalence of a positive screening for neurocognitive impairment (NCI) HIV infected and uninfected men who have sex with men (MSM) population using the Basic Neurocognitive Score (BNCS) and International HIV Dementia Score (IHDS) as validated screening tools

  • Change in neurocognitive function [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    To follow neurocognitive function over time in a cohort of HIV infected and uninfected MSMs


Secondary Outcome Measures:
  • Demographics [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    To explore possible correlations between baseline demographics and disease characteristics and prevalence of positive screens for anxiety and/or depressive symptoms and NCI

  • Biomarkers [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    To look for possible markers of NCI on MRI scanning or on serological/CSF analysis


Enrollment: 237
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV infected
HIV infected MSM 18-50 years old
HIV uninfected
HIV uninfected MSM 18-50 years old

Detailed Description:

The aim of this project is to examine neurocognitive functioning in HIV infected men who have sex with men (MSMs). We have limited our study to this group in order to better study other shared risk factors (hepatitis coinfection, recreational drug use). Given ongoing work in an older cohort our aim is to study neurocognitive impairment in younger subjects (18-49 years). There are two parts to this study. The first is a cross sectional pilot (MSM Neurocog-1) looking at neurocognitive function in HIV infected and HIV uninfected MSMs. The second plan is for a prospective 48 week cohort study 24-48 week study (MSM Neurocog-2) following neurocognitive function in HIV infected subjects and a group of HIV uninfected controls over time.

The shift in HIV care to that of a chronic, manageable condition has transferred focus to long-term morbidities and drug toxicities. One such area in which there is renewed interest is the prevalence and relevance of neurocognitive impairment, as well as the significance of compartmentalised virus in the CSF as compared to blood. Controlled, comparative data are lacking - many of the cross-sectional studies to date have not controlled for important confounders such as recreational and injecting drug use, current or prior co-infections or co-morbidities. Where this has happened, researchers generally use general population controls that may differ markedly from HIV-infected individuals in terms of lifestyle and demographic factors. In addition the paucity of longitudinal data means it is unclear whether an individual with normal neurocognitive function pre-ART will develop impairment later or if subjects with evidence of impairment can expect improvement or normalisation over time; these issues are highly important for clinical management and patient counselling. There is no consensus on which surrogate markers, if any, are important in terms of diagnosing, monitoring and/or predicting neurocognitive impairment. Studies measuring correlation between neurocognitive performance and neuronal markers of inflammation have been conflicting.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV infected and uninfected MSM 18-50 years old

Criteria

Inclusion Criteria:

All subjects

  • 18-49 years inclusive
  • Identifying as MSM
  • Willing and able to provide written informed consent
  • Able to complete screening tools.
  • Fluent in spoken and written English
  • Patients who have given written and dated informed consent to participate in this study and to use the data.
  • Patients co-infected with chronic hepatitis B/C (diagnosed serologically at least 6 months prior to study to exclude seroconversion/recent infection) and/or currently using recreational substances including alcohol will be included in this study ("real world" data)

HIV-infected subjects • Known HIV of at least 6 months duration (in order to exclude symptoms associated with primary HIV infection)

HIV-uninfected controls

  • HIV-negative by rapid point of care test (POCT) or standard laboratory testing
  • No unprotected anal intercourse (UPAI) in last 3 months

Exclusion Criteria:

All subjects

  • HIV or hepatitis B/C infection thought to have occurred in the last 6 months
  • Current/active central nervous system (CNS) opportunistic infections or CNS malignancies.
  • Previous cerebrovascular accidents (CVA/stroke) or history of transient ischemic attacks (TIAs).
  • Neuromuscular disease that will limit ability to perform the screening tests.
  • Patients receiving current therapy with ribavirin or interferon for hepatitis co-infection or expected to start such therapy in the coming 12 months
  • Current medical or psychiatric/psychological condition deemed significant by the investigator o (e.g. psychosis, bipolar disorder, dementia, eating disorders, severe head injury (loss of consciousness for at least an hour), current CNS opportunistic infection)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508559

Locations
United Kingdom
SSAT Clinical Trials Unit
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Brian Gazzard, Prof St Stephen's AIDS Trust
  More Information

No publications provided

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01508559     History of Changes
Other Study ID Numbers: MSM Neurocog
Study First Received: January 9, 2012
Last Updated: April 10, 2014
Health Authority: UK: National Research Ethics Service

Keywords provided by St Stephens Aids Trust:
HIV
Neurocognitive

ClinicalTrials.gov processed this record on October 01, 2014